Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'

NCT06336044 | Recruiting

• 1 other identifier: Taufiller/22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events

Conditions

Wrinkle; Scar; Laxity; Skin

Keywords

hyaluronic acid; Collagen; Filler; Wrinkles

Outcome Measures

Primary Outcomes (5)

• Safety: no adverse events

  test the safety of the device evaluating any potential adverse event

  16 weeks

• Efficacy: change of wrinkles and scars

  test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale

  16 weeks

• Efficacy: change of wrinkles and scars

  test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)

  16 weeks

• Efficacy: change of wrinkles and scars

  test the efficacy of the device measuring the skin surface evaluating the face volume

  16 weeks

• Efficacy: change of wrinkles and scars

  test the efficacy of the device measuring the skin surface with skin hydratation measurement

  16 weeks

Secondary Outcomes (1)

• Duration of the efficacy

  16 weeks

Study Arms (2)

Face treatment

EXPERIMENTAL

Patients treated for face needs with Karisma micro injections

Device: Karisma

Lips treatment

EXPERIMENTAL

Patients treated for face needs with Karisma microinjections

Device: Karisma

Interventions

Karisma DEVICE

Intradermal injection

Also known as: Karisma filler

Face treatment; Lips treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all sexes
• caucasic
• to 70 years
• non smoker

You may not qualify if:

• Pregnancy
• milking
• smoker
• alcohol or drugs abuse
• change of BMI during the study
• previous facial surgery, implants, permanent treatments
• sensitivity to the product
• dermatological difficult frame
• health weakness
• treated with anticoagulants, antihistaminics, corticosteroids, antidepressants and other drugs impacting on the results

Sponsors & Collaborators

• Taumedika s.r.l.: lead
• Nextrasearch S.r.l.s.: collaborator

Study Sites (1)

Ospedale Tor Vergata

Roma, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Cicatrix; Cutis Laxa

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Adolfo Gasparetto, MD

  Nextrasearch S.r.l.s.

  STUDY DIRECTOR

Central Study Contacts

Elena Campione, Professor

CONTACT

+393382445642; elena.campione@uniroma2.it

Adolfo Gasparetto, MD

CONTACT

+393356641965; adolfogasparetto@nextrasearch.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 20 patients for face and 20 for lips will undergo skin characterists measurments at time 0 at +4weeks and at +16 weeks

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 28, 2024
• Study Start: February 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)